Associate Scientist / Scientist — Process Development Upstream

JOINN Biologics (JOINN Bio) is a Bay Area, California-based company that is committed to the advancement of biopharmaceutics through its premier contract development and manufacturing services for biologics and advanced therapies. JOINN Biologics aims to provide a complete range of services from early custom development to clinical manufacturing to our global clients. We will work closely with our partners and clients to further accelerate the development of high-quality biologics and deliver long-lasting value to the biopharmaceutical industry. The near-term goal of the company is to recommission the cGMP facility in JOINN Innovation Park and provide contracted manufacturing services soon.

We are seeking Associate Scientists or Scientists in Department of Process Development Upstream, the incumbent will work with internal and external partners, to support bulk process development, characterization, technology transfer, and validation studies associated with the development and implementation of manufacturing processes, systems and facilities related to therapeutic mAbs and proteins.
Responsibilities:

• Develop methods for transferring procedures/processes from laboratories to commercial-scale manufacturing production
• Design, develop and execute cell culture studies using aseptic technique in shaker flasks, glass bench scale bioreactors, and single-use bioreactors
• Acts as a Subject Matter Expert (SME) to train others in areas of expertise. Assists and offers guidance to the Process Development group and Manufacturing group as necessary to train on correlated processes
• Responsible for the data review and analysis; prepare presentations, project plans as needed for internal and external discussions
• Authoring/reviewing development reports, process transmittals, and manufacturing records
• Identify and evaluate new/innovative technologies and work to implement new platforms with cross-functional early and late stage development teams
• Collaborate with Manufacturing, Quality, Engineering, Validation staff to ensure manufacturing process equipment meets quality standards and is acceptable for use in clinical and/or commercial manufacturing
• Good understanding of Quality by Design and Risk Management

Required Experience and Skills:

• Knowledge and skill of mammalian cell cultures and concepts of cell metabolism, protein production, and characterization
• Experience in upstream biologics process development and manufacturing sciences, such as cell cultivation in shaker flasks and bioreactors
• Skill and knowledge of scaling up to 50 L or more in single-use technologies
• Working knowledge of design of experiments and use of statistics for data analysis
• Ability to think critically with excellent problem solving and troubleshooting skills
• Excellent communication and ability to work independently and in a collaborative environment
• Ability to execute studies and experiments in the context of long-term commercialization plans

EDUCATION REQUIREMENTS:

• Ph.D. degrees in chemical engineering, bioengineering, biochemistry, biotechnology, biology, or a related field and 0-2 years of work experience or B.S./M.S. and 0-5 years of work experience.

Equal Opportunity Employer. We offer the successful candidate a competitive compensation and benefits package.

Job Type: Full Time
Location: Richmond, CA 94806
Work authorization: United States (Required)